• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION AK 96 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 110661
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that smoke was coming from an ak 96 machine and the operator panel was not responsive. This event occurred during an unspecified process step of hemodialysis treatment. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAK 96 MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - LUND MONITORS
magistratsvagen 16
lund skane lan SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12264342
MDR Text Key264687716
Report Number9616026-2021-00038
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-